An Observational Study of the Nutritional Status in Locally Advanced or Metastatic Solid Cancer Patients While Receiving Immunotherapy in Spain: the NutriOncoSearch (NOS) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 586
- 试验地点
- 11
- 主要终点
- Nutritional status
研究概览
简要总结
Malnutrition is a common medical problem in oncology patients. It is well known that the presence of malnutrition negatively affects patients' evolution and their quality of life, increasing the incidence of infection, hospital stay, and mortality.
The new knowledge of cancer biology has made it possible to know the mechanisms of cancer progression.
New treatments have been developed thanks to this knowledge including molecular target treatments aimed at these cancer mechanics and to reverse the antitumor capacity of the immune system. However, these treatments have different toxicities than classic and anachronistic treatments such as chemotherapy and radiotherapy, including alterations in glucose metabolism, endocrinopathies, rhabdomyolysis, etc. that can alter both the patient's nutritional status and quality of life. Additionally, a deficient nutritional status can have an impact on the intestinal microbiota, compromising the efficacy of the new antitumor treatments.
The principal objective of this study is to characterize the nutritional status of the cancer outpatient receiving immunotherapy through a screening performed in Hospital consultations in Spain.
Secondary Endpoints are (a). To describe the percentage of patients that receive nutritional counseling or nutritional support (enteral and/or parenteral nutrition) among those diagnosed as malnourished or at risk. And (b) to categorize the percentage and descriptive characteristics of cancer patients with mild, moderate, or severe malnutrition that goes to a hospital consultation in Spain and describe the percentage and descriptive characteristics of patients with malnutrition according to sociodemographic and clinical characteristics.
详细描述
Study Title:
An observational study of the Nutritional status in locally advanced or metastatic solid cancer patients while receiving immunotherapy in Spain: the NutriOncoSearch (NOS) study.
Research Question:
What is the current nutritional status in advanced cancer patients receiving immunotherapy or any other targeted therapies in Spain?
Study Background & Rationale:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients, over 18 years old, with locally advanced or metastatic solid tumors (with the idea of homogenizing the sample as far as possible and in line with what has been published up to now, also stratified in line with Globocan).
- •Patients under immunotherapy treatment either exclusively or in combination with chemotherapy or radiotherapy. Immunotherapy defined by checkpoint treatments inhibitors PD-1, PDL-1 y CTLA-
- •At least 12 weeks of treatment.
排除标准
- •Estimated survival below 12 weeks (palliative criteria).
- •Patients that meet diagnostic criteria (DSM-IV and ICD-10) of nervous anorexia and bulimia.
- •Patients with severe psychiatric disorders.
结局指标
主要结局
Nutritional status
时间窗: Six months
To characterize the nutritional status of the cancer outpatient receiving either immunotherapies or any other targeted therapies through a screening performed in Hospital consultations in Spain.
次要结局
- Nutritional counselling(Six months)
- Descriptive characteristic mild, moderate or severe malnutrition(Six months)
研究者
Julio C. de la Torre-Montero
Principal Investigator, professor
Universidad Pontificia Comillas